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| Sponsor: | Rambam Health Care Campus |
|---|---|
| Information provided by: | Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT00347867 |
Purpose
It has been suggested that Viagra (or other drugs that inhibit PDE-5, the enzyme that normally inhibits blood vessels’ ability to expand) may have beneficial effects in hypertensive pregnancy and, possibly, preeclampsia.The benefits of Viagra were observed without any reduction in maternal blood pressure, thereby dissociating hypertension per se from the loss of NO (nitrous oxide) signaling in the uterine circulation.Following publications, suggesting that sildenafil citrate used as a therapeutic agent may improve myometrial perfusion in IUGR gestations by promoting myometrial small artery vasodilatation, decreasing peripheral resistance and increasing flow within the uteroplacental bed, we intend to administer this medication to parturients where intauterine growth restriction and pregnancy associated hypertension have been diagnosed in an attempt to induce vasodilatation and improved uteroplacental perfusion resulting in improved fetal growth.
| Condition | Intervention | Phase |
|---|---|---|
|
IUGR |
Drug: Viagra administration in IUGR/PET pregnancies |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Improvement of Utero-Placental Perfusion and Fetal Growth in IUGR and PET by Administration of Sildenafil Citrate in Pregnancy |
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2006 |
Each participant will receive, after informed consent a 25 mg tablet of Viagra [sildenafil citrate ]orally. The uteroplacental perfusion will be measured using transvaginal and transabdominal ultrasound Doppler velocimetry studies, before and after 2, 4, and 24 hours of Viagra ingestion. If no significant side effects are recorded, the protocol will be repeated , 48 hours after the first tablet ingestion, but using 50 mg Viagra.In cases of positive and encouraging results and if no serious side effects are detected we shall consider repeated administration of the lowest effcetive dose of viagra in an attempt to prevent prematurity and possibly reach term.our study will evaluate the effects of Viagra on uterine blood flow changes during pregnancy, and possible changes in other systems that contribute to normal fetal growth and development, in parallel to monitoring general and possible deleterious effects on the retina or other possible maternal or fetal organs.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Zeev Blumenfeld, MD | 972-4-8542577 | z_blumenfeld@rambam.health.gov.il |
| Israel | |
| RAMBAM Health Care Campus | |
| Haifa, Israel, 31096 | |
| Principal Investigator: | Zeev Blumenfeld, MD | RAMBAM Health Care Campus, Technion |
More Information
| Study ID Numbers: | Viagra.CTIL |
| Study First Received: | July 3, 2006 |
| Last Updated: | July 3, 2006 |
| ClinicalTrials.gov Identifier: | NCT00347867 History of Changes |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
IUGR PET Pregnancy Viagra Sildenafil citrate |
|
Vasodilator Agents Pregnancy Complications Molecular Mechanisms of Pharmacological Action Sildenafil Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions |
Fetal Diseases Pathologic Processes Phosphodiesterase Inhibitors Therapeutic Uses Growth Disorders Fetal Growth Retardation |
